Parameters For IRB Review And Approval Of Electronic Consent Documents

By David Forster, JD, MA, CIP, Chief Compliance Officer, WCG

The IRB must review consent documents to ensure that the elements of consent in 45 CFR 46.116 and 21 CFR 20.25 are included as appropriate, and to ensure that there is appropriate documentation of consent. IRBs have the authority to approve a consent form as written, to give conditional approval of a consent form, or to defer or disapprove the consent form if extensive changes are necessary. The requirements for conditional approval are provided in the OHRP “Guidance on IRB Approval of Research with Conditions.” FDA agrees with the provisions in this OHRP guidance.